Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201610001812290 Date of Approval: 06/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving blood glucose control with a lunch-time dose of regular insulin in diabetic patients on twice daily mixed insulin
Official scientific title Assessment of the effect of mid-day pre-prandial bolus dose of regular insulin on glycemic control in diabetic patients on twice daily pre-mixed insulin therapy at Borg Al-Arab Hospital Internal Medicine Clinic: An open label randomized trial
Brief summary describing the background and objectives of the trial Clinical Practice Guidelines for management of type 1 diabetic patients recommend the use of intensive insulin regimen to provide adequate glycemic control. However, economic constraints could trigger the use of other alternatives in real-world practice. The Egyptian Ministry of Health supplies only two types of insulin for management of diabetes, premixed insulin and regular insulin. Although premixed insulin is used for some diabetic patients for convenience, it is generally associated with poor glycemic control and constitutes the only option available for patients treated in the Ministry of Health units. In an attempt to improve control on pre-mixed insulin, some practitioners add a bolus dose of regular insulin before the largest meal of the day to the premixed twice daily regimen.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diabetes,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2016
Actual trial start date
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 130
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization done via a draw Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Follow up only Twice daily dosing of pre-mixed insulin continued as originally estimated by prescriber 9 months Patients will continue previously prescribed twice daily pre-mixed insulin without change 65 Active-Treatment of Control Group
Experimental Group Mid-day pre-prandial bolus dose of regular insulin Dose will be determined using 1700/(total daily insulin) to bring post-prandial blood glucose level to 180 mg/dl 9 months In addition to previouslyprescribed twice daily pre-mixed insulin, patients will recieve a single pre-prandial bolus dose at lunch time 65
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Receiving twice daily insulin only Have access to a nearby pharmacy or a healthcare unit Have access to a phone Baseline HbA1c% of 8 or above History of severe hyperglycemia, high risk of hyperglycemia and/or hyperglycemia unawareness Renal and hepatic patients Patients with uncontrolled ischemic heart disease Patients on beta-blockers, glucocorticoids, insulin secretagogues Pregnant and lactating women 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/10/2016 Medical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Alexandria University Alexandria Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lowering HbA1c% to below 7 Baseline 3 months 3 months 3 months
Secondary Outcome Reduction of the progression of diabetic nephropathy measured as albumin/creatinine ratio At baseline and every three months thereafter for 9 months
Secondary Outcome Assessment on changed insulin ordering patterns and insulin shortages Monthly with every new order
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Borg El-Arab Hospital Internal Medicine Clinic Fifth Neighborhood Borg El-Arab Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Borg El-Arab Central Hospital Fifth neighbourhood Borg El-Arab Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Borg El-Arab Hospital, Ministry of Health Fifth neighbourhood New borg El-Arab City Egypt Hospital
Secondary Sponsor Alexandria University El-Khartoom Square, Azarita Alexandria 21521 El-Mesallah Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed El-Yazbi Faculty of Pharmacy, Alexandria University Alexandria Egypt
Ola El-Gaddar Medical Research Institute, Alexandria University Alexandria Egypt
Maha Taha Borg El-Arab Hospital Borg El-Arab Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El-Yazbi ahmed.fawzy.aly@alexu.edu.eg +961 76 012 686 Faculty of Pharmacy, Alexandria University
City Postal code Country Position/Affiliation
Alexandria Egypt Associate Professor
Role Name Email Phone Street address
Public Enquiries Maha Taha maha.abdullatief@gmail.com +20 11 1966 8318 Borg El-Arab Hospital
City Postal code Country Position/Affiliation
Borg El-Arab Egypt Pharmacist
Role Name Email Phone Street address
Scientific Enquiries Ola Elgaddar Ola.Elgaddar@alexu.edu.eg +20 10 0607 3883 Medical Research Institute, Alexandria University
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor
REPORTING
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Result URL Hyperlinks Link To Protocol
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Changes to trial information